On this page
Audenz
Influenza A (H5N1) Monovalent Vaccine, Adjuvanted
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Audenz
Proper name
Influenza A (H5N1) Monovalent Vaccine, Adjuvanted
Licence type
351(a)
BLA number
125692
Applicant
Seqirus Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 7.5HA UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Disc | January 31, 2020 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |